FDA List of Authorized Generics: Where to Find and How to Use It

When you're looking for a cheaper version of a brand-name drug, you might think all generics are the same. But there's a type of generic you probably haven't heard of-authorized generics. These aren't just copies made by another company. They're the exact same drug as the brand-name version, made by the original manufacturer, just sold without the brand name on the label. They look different-maybe a different color or shape-but inside, they're identical. And if you're trying to save money on prescriptions, knowing where to find the official list of these drugs can make a real difference.

What exactly is an authorized generic?

An authorized generic is a brand-name drug that the original company sells under a different label, usually at a lower price. It's not a separate product approved through the generic pathway. Instead, it's made under the same New Drug Application (NDA) as the brand version. That means it uses the same ingredients, same factory, same quality controls. The only difference? No brand name on the bottle.

For example, if you take CLEOCIN T topical gel for acne, the brand version is made by Pfizer. But Pfizer also makes an authorized generic version of that same gel-same formula, same strength, same packaging except without the CLEOCIN name. It's sold to pharmacies at a discount, so you pay less. This isn't a loophole. It's a legal product tracked by the FDA under Section 505(t) of the Federal Food, Drug, and Cosmetic Act, passed in 2003.

Why does this matter? Because not all generics are created equal. Traditional generics go through a different approval process (ANDA), and sometimes they're made by third-party companies that might use slightly different fillers or coatings. Authorized generics skip that whole step-they're the original drug, just rebranded. If you need consistency-say, you're switching from brand to generic and don't want any change in how the drug works-authorized generics are the safest bet.

Where to find the official FDA list

The only place to get the complete, legally required list of authorized generics is on the FDA's website. Go to fda.gov/drugs/abbreviated-new-drug-application-anda/fda-list-authorized-generic-drugs. That’s the only official source.

The list is published as a downloadable PDF, updated every three months. The most recent version as of October 10, 2025, contains over 800 entries. Each row includes:

• The brand name (like ACTIQ or ARTHROTEC)
• The dosage form (tablet, gel, capsule)
• The strength (e.g., 1200 mcg, 1% lotion)
• The name of the brand manufacturer (like Pfizer Inc. or Cephalon, LLC)
• The date the authorized generic first entered the market

Don’t expect a search bar or filters. It’s a static PDF. That means you have to scroll through pages to find what you need. If you’re looking for a specific drug, use Ctrl+F (or Command+F on Mac) to search the PDF for the brand name.

Why isn’t it a live database? Because the FDA only gets this data once a year from manufacturers, in their annual reports. The date listed isn’t necessarily when the drug hit shelves-it’s when the company reported it to the FDA. So if a drug was pulled from the market last month, it might still show up on the list.

How this list is different from the Orange Book

You might have heard of the FDA’s Orange Book. It’s where you find approved generic drugs and their therapeutic equivalence ratings. But here’s the key difference: authorized generics are not in the Orange Book.

The Orange Book tracks drugs approved through ANDAs-generic versions made by other companies. Authorized generics are made by the brand company itself and are listed under the original NDA. That means if you search the Orange Book for a brand-name drug and see no generics listed, it doesn’t mean there aren’t cheaper options. There might be an authorized generic, but you won’t find it there.

For example, the brand drug ARTHROTEC (diclofenac/misoprostol) has no ANDA-approved generics in the Orange Book. But the FDA’s authorized generics list shows Pfizer started selling an authorized version in November 2012. If you only checked the Orange Book, you’d miss this option entirely.

Why the list can be misleading

The FDA list is accurate-but incomplete in practice. It tells you what was reported, not what’s available.

Pharmacists and patients have reported frustration with this gap. One independent pharmacy owner in Ohio found that 5 out of 8 authorized generics listed were no longer stocked by his wholesaler. Another pharmacist in Texas said she used the list to switch a patient to an authorized generic, only to find the pharmacy couldn’t order it because the manufacturer had stopped shipping it months earlier.

The FDA admits this. Their disclaimer says: “The list may include only information that is included in an annual report. FDA does not have information on whether the AG is still marketed.”

That means the list is great for research, competitive analysis, or academic use-but not for daily prescribing or purchasing decisions. If you’re a patient or pharmacist trying to save money, you need to cross-check with your pharmacy’s formulary or your wholesaler’s catalog. Look up the National Drug Code (NDC) for the authorized generic and verify it’s active in the NDC Directory.

Who’s using authorized generics-and why

Brand-name drug companies use authorized generics as a strategic tool. When a patent expires, a generic competitor can get 180 days of exclusive market access. During that time, they can charge high prices. To undercut them, the brand company releases its own authorized generic at a lower price-right away. This keeps market share and prevents the first generic from dominating the market.

According to a 2023 study in Health Affairs, over 850 authorized generics launched between 2010 and 2019. Pfizer, Teva, and Viatris (formerly Mylan) are the top three manufacturers. Pfizer alone has 47 authorized generics on the list.

But here’s the catch: the savings aren’t always huge. A 2020 JAMA Internal Medicine editorial pointed out that authorized generics often cost only 10-20% less than the brand name-not the 50-80% discounts you see with traditional generics. That’s because the brand company still controls pricing. Still, for patients on high-deductible plans or without insurance, even a small discount adds up.

On the flip side, some experts argue authorized generics help keep prices in check. If a first generic tries to charge too much during its exclusivity period, the brand can drop its authorized version at a lower price and force the competitor to follow suit. It’s a market balancing act.

What’s coming next

The FDA has said it plans to replace the PDF list with a searchable, online database by mid-2026. That’s a big step forward. Stakeholders-from pharmacists to insurers-have been asking for this for years. The current PDF is hard to use, outdated, and doesn’t show real-time availability.

There are also talks of linking the authorized generics list to the FDA’s Drug Shortage Portal and price transparency rules under the Inflation Reduction Act. That could mean future versions will show not just what’s been reported, but what’s actually on shelves and at what price.

Until then, the PDF remains the only official source. And while it’s not perfect, it’s the only place that tells you which brand-name drugs have authorized versions-and who makes them.

How to use this list effectively

If you’re a patient:

• Check the FDA list for your brand-name drug to see if an authorized generic exists.
• Ask your pharmacist: “Is there an authorized generic version of this drug?”
• Don’t assume it’s available-call your pharmacy or wholesaler to confirm stock.

If you’re a pharmacist or prescriber:

• Use the list to identify cost-saving alternatives for patients.
• Verify NDC codes in the FDA’s NDC Directory to confirm active status.
• Pair FDA data with weekly NDC deactivation reports from your distributor to avoid ordering discontinued products.

If you’re a researcher or analyst:

• The list is invaluable for tracking manufacturer strategies and market entry timing.
• Combine it with commercial data from IQVIA or other sales databases to get a full picture of availability.

Bottom line: The FDA’s authorized generics list isn’t a shopping guide. It’s a transparency tool. It doesn’t tell you what’s in stock. But it does tell you what’s legally allowed-and who’s making it. That’s powerful information if you know how to use it.